In order to evaluate the significance of an estimated dietary exposure to genotoxic
compounds the exposure basically compared with the dose leading to a specified
incidence of tumor formation in experimental animals. The larger the margins between
the effect dose level and the actual exposure level (margins of exposure, MOE) the
lower is the concern. An internationally recognized toxicological reference point is
the Benchmark Dose Lower confidence Limit (BMDL), which represents the exposure
level where an increase in the incidences of the effect (at 10% in case of animal
experiments) is smaller than the specified Benchmark Response with a confidence
of 95% (Zeilmaker et al., 2010). The BMDL10 may be derived from dose–response data
from several long-term carcinogenicity studies instead of one extensive study. For
genotoxic compounds EFSA has expressed that if the BMDL10 is 10,000 times higher
than the exposure (i.e. MOE of 10,000), the exposure is of lowconcern (EFSA, European
Food Safety Authority, 2012).